1.07337
Paraffin
56-58, in pastille form Ph Eur,BP,NF
Synonym(s):
Paraffin
agency
BP, NF, Ph. Eur.
form
solid
autoignition temp.
>300 °C
potency
>5000 mg/kg LD50, oral (Rat), >3600 mg/kg LD50, skin (Rabbit)
bp
>300 °C/1013 hPa
mp
42-72 °C
density
0.90 g/cm3 at 20 °C
Quality Level
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Analysis Note
Identity: passes test
Acidity or alkalinity: passes test
Solidification point: 56 - 58 °C
Aromatic, polycyclic Hydrocarbons: conforms
Residual solvents (Ph Eur/ICH): excluded by manucfacturing process
Readily carbonisable substance: passes test
Sulfate (SO₄): ≤ 0.015 %
Sulfur compounds: passes test
corresponds to Ph Eur,BP,NF
Acidity or alkalinity: passes test
Solidification point: 56 - 58 °C
Aromatic, polycyclic Hydrocarbons: conforms
Residual solvents (Ph Eur/ICH): excluded by manucfacturing process
Readily carbonisable substance: passes test
Sulfate (SO₄): ≤ 0.015 %
Sulfur compounds: passes test
corresponds to Ph Eur,BP,NF
Regulatory Information
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